Fujirebio Expands Access to Blood-based Neurology Testing in Brazil with ANVISA Market Authorization for Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma

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Postmedia has not reviewed the content. by Business Wire Fujirebio Expands Access to Blood-based Neurology Testing in Brazil with ANVISA Market Authorization for Lumipulse® G NfL Blood and Lumipulse G pTau 217 PlasmaAuthor of the article:GHENT, Belgium & TOKYO — H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted market authorization for the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for use on the fully automated LUMIPULSE® G immunoassay platform in Brazil.THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an Account“ANVISA authorization of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays marks another important step in our mission to expand access to reliable, clinically meaningful blood-based biomarkers for clinicians and patients worldwide,” said Christiaan De Wilde, CEO of Fujirebio Europe N.V. “By making both neurological biomarker assays available to laboratories on a single, fully automated platform, we are helping support more informed clinical decision-making across a broad range of neurological conditions and throughout the diagnostic pathway.”The Brazilian ANVISA authorizations are based on the already CE marked in vitro diagnostics (IVD) approvals of these two assays, reflecting conformity with the safety and performance requirements of the different regulatory agencies. The assays were also granted Class II Medical Device Licenses (MDL) by Health Canada earlier this month. Together, these milestones broaden access to Fujirebio’s high-quality biomarker solutions and strengthen its comprehensive neurological diagnostics portfolio. Through its expanding menu of blood-based and cerebrospinal fluid (CSF) biomarkers, Fujirebio aims to contribute to a timelier diagnosis, more informed treatment decisions and improved patient care in neurological disease.Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againAbout Lumipulse G NfL BloodThe Lumipulse G NfL Blood assay is intended for the quantitative measurement of neurofilament light chain (NfL) in human serum and plasma.NfL is a well-established biomarker of neuro-axonal injury and has been studied across a wide range of neurological conditions, including for its potential utility in disease monitoring, prognosis, and assessment of treatment response. This broad applicability underscores the value of linking the biomarker to the pathophysiology it represents rather than to a disease.Results from the Lumipulse G NfL Blood assay should be interpreted in the clinical context and with appropriate reference values and validated clinical decision frameworks.About Lumipulse G pTau 217 PlasmaTau phosphorylated at threonine 217 (pTau 217) is a highly specific blood-based biomarker associated with Alzheimer’s disease (AD) pathology. It can support the assessment of underlying amyloid pathology and help clinicians distinguish AD from other causes of cognitive decline.The Lumipulse G pTau 217 Plasma assay is intended to aid healthcare providers in identifying amyloid pathology associated with AD in individuals aged 50 years and older who present themselves with signs and symptoms of cognitive decline in specialized care settings. The assay is to be used as an adjunct to other diagnostic evaluations.Fujirebio is a diagnostics company with over 75 years of experience delivering innovative solutions to healthcare providers, pharmaceutical companies, and IVD partners worldwide. Leveraging world-class expertise in neurology, oncology, infectious diseases, and beyond, and assays available on the robust LUMIPULSE® G platform, Fujirebio’s open business model accelerates access to breakthrough diagnostics through strategic partnerships across the life science industry.Part of H.U. Group, Fujirebio combines strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions. Fujirebio’s flexible CDMO model helps its diagnostic partners bring validated solutions to the market faster, driving better decisions, treatments, and patient outcomes.For more information, please visit www.fujirebio.com Lumipulse is a registered trademark of Fujirebio Inc.View source version on businesswire.com: For media: Public Relations Section, Public Relations/Sustainability Department, H.U. Group Holdings, Inc. Phone: +81-3-6279-0884 E-mail: pr@hugp.com Christiaan De Wilde CEO Fujirebio Europe Phone: +32 9329 1703This advertisement has not loaded yet.Notice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. Read more about cookies here. By continuing to use our site, you agree to our Terms of Use and Privacy Policy.